Motivational Interviewing to Improve Self Management in Youth With Type 1 Diabetes

Not Applicable

Completed

• Conditions: type1diabetes
• Interventions: Other: Motivational interviewing

• Registration Number: NCT04798937
• Lead Sponsor: Université de Sousse

Brief Summary

A brief, nurse-led educational intervention using motivational interviewing substantially improved general and disease-specific self-management skills in youth with type 1 diabetes.

Detailed Description

Introduction and Objectives: For youth with chronic health conditions, adolescence is associated with a deterioration of disease self-management and poor health outcomes. Effective interventions are needed to prepare youth for transition to adulthood and adult care. To prospectively assess the impact of an education program based on motivational interviewing on self-management skills and glycemic control in youth with Type 1 diabetes (T1D).

Methods: After parental consent and youth assent, investigators prospectively randomized 66 adolescents 13-18 years old with type 1 diabetes to either usual care (regular medical consultation) or usual care supplemented by sessions with a nurse educator using a motivational interviewing (MI) approach and goal setting based on responses to the Transition Readiness Assessment Questionnaire (TRAQ) and T1D specific self-management skills. Primary outcomes were TRAQ change scores and HbA1c levels between baseline and 6 months.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Status Verified: 2021-03
• Study First Submitted: 2021-03-07
• Study First Submitted QC: 2021-03-12
• Last Update Submitted: 2021-03-12
• Study First Posted: 2021-03-15
• Last Update Posted: 2021-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Being diagnosed with type 1 diabetes
• Having an age between 13 and 18 years

Exclusion Criteria

• Having a neurological disability (epilepsy, autism)
• Having a significant intellectual delay, which might have affected their ability to understand the content of the program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Motivational interviewing	Youth in this group received usual care, consisting of medical consultations, in combination with a health education program based on motivational interviewing provided by a nurse

Primary Outcome Measures

Name	Time	Method
Transition Readiness Assessment Questionnaire (TRAQ) scores	Change from Baseline TRAQ score at 6 months	The TRAQ includes 20 items divided into five subscales: 1) Appointment keeping (7 questions; e.g., Do you call the doctor's office to make an appointment?) 2) Tracking health issues (4 questions; e.g., Do you keep a calendar or list of medical and other appointments?); 3) Managing medications (4 questions; e.g., Do you know what to do if you are having a bad reaction to your medications?); 4) Talking with healthcare providers (2 questions; e.g. Do you tell the doctor or nurse what you are feeling?); 5) Managing daily activities (3 questions; e.g. Do you help plan or prepare meals/food?). Each question has the same Liker response set from 1 to 5 using the Stages of Change Transtheoretical Model as a framework. A minimum score of ''1'' is assigned to the responses 'No, I don't know how' while a maximum score of '' 5 '' is assigned to responses labeled "Yes, I always do it when I need it." Higher scores mean better outcome.

Secondary Outcome Measures

Name	Time	Method
Hemoglobin glycated values	Change from Baseline Hemoglobin glycated values at 6 months	Hemoglobin glycated values

Trial Locations

Locations (1)

Farhat Hached University Hospital; 🇹🇳 Sousse, Tunisia